Controlled Substance Manufacturing Considerations: DEA Quotas

By Bob Forner, Cedarburg Hauser Pharmaceuticals

United States based controlled substance manufacturers must adhere to the Controlled Substance Act (CSA), which is enforced by the US Drug Enforcement Agency (DEA) and regulates the manufacture, importation, possession and distribution of certain substances. The rules and regulations governing the manufacture of controlled substance are laid out in the Title 21 Code of Federal Regulations (CFR), Part 1300-1399. These regulations add layers of complexity to the already complicated drug manufacturing process. A number of factors must be considered when looking to either procure or manufacture controlled substances due to these complexities. Of these considerations, obtaining DEA quotas likely has the most substantial impact on timelines.

Establishing an Aggregate DEA Quota
As a provision of the CSA, the DEA must establish aggregate production and procurement quotas for basic classes of Schedule I and II controlled substances. These quotas establish the maximum amount of controlled substance that may legally be manufactured in the United States. Quotas are determined by a number of factors, both internationally and domestically:

1. Amount manufactured during the current and preceding two years
2. Trends in world-wide use
3. Current inventory and inventory trends
4. Projected demand as indicated by procurement quotas requested
5. Situational considerations